MAUDE Adverse Event Report: MYRIAD GENETICS BRACANALYSIS; NONE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  Other  

Event Description

Vencken and colleagues suggest that brca1 and brca2 patients who develop ovarian cancer are more responsive to platinum-based chemotherapy than patients without brca1/2 mutations who develop sporadic ovarian cancer.This presents an opportunity for personalizing the treatment for ovarian cancer.Unfortunately, it is difficult for this info to be included in the label for cisplatin because there seems to be no clinical trial data presented to the fda about personalizing cisplatin treatment based on the brca1/2 mutations.Nevertheless, it is important to the fda to prevent misuse and misinterpretation of the brca1/2 tests.Therefore this info should be provided to patients and practitioners who ultimately interpret the results of the brca1/2 tests after a purchase of that test.As an example of a product use error, brca1/2 patients and their doctors may sometimes have the false impression that platinum compounds are ineffective in patients who test positive for brca1/2.As a consequence, those patients are not given platinum compounds despite that they may benefit from that treatment.Table 3 of vencken et al., suggests that progressive disease would be a consequence of using non-platinum-based chemotherapy.Therefore, i propose that the brca1/2 tests include a warning clarifying that patients who test positive for brca1 or brca2 do not necessarily have cancer that is resistant to platinum compounds.Vencken, p.M.L.H., mieke kriege, d.Hoogwerf, s.Beugelink, m.E.L.Van der burg, m.J.Hooning, e.M.Berns et al."chemosensitivity and outcome of brca1-and brca2-associated ovarian cancer patients after first-line chemotherapy compared with sporadic ovarian cancer patients".Annals of oncology 22, no.6 (2011): 1346-1352.

• Brand Name: BRACANALYSIS
• Type of Device: NONE
• Manufacturer (Section D): MYRIAD GENETICS; salt lake city UT 84108
• MDR Report Key: 3934652
• MDR Text Key: 20327710
• Report Number: MW5037253
• Device Sequence Number: 1
• Product Code: OQS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CISPLATIN